Associate Medical Director, Medical Safety EvaluationMedical Director, Medical Safety Evaluation
Associate Medical Director, Medical Safety EvaluationMedical Director, Medical Safety Evaluation
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Purpose:
Supporting the Product Safety Leads (PSTLs) and potentially leading one or more products as the PSTL under the direction of the Group Medical Director and Executive Medical Director in ensuring safety through surveillance signal detection validation and assessment. Interpreting regulations related to pharmacovigilance supporting all patient safety activities.
Responsibilities:
Understands and applies he pharmacology chemistry and non-clinical toxicology to effectively conduct safety surveillance
Safety surveillance for pharmaceutical / biological / drug device combined products contributes to the authorship of key pharmacovigilance documents including but not limited to medical safety assessments regulatory responses and risk management plans
Applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyzes and interprets aggregate safety data and communicate these analysis and interpretation to cross-functional teams
Effectively writes reviews and provides input on technical documents.
Leads the strategy for periodic reports (DSURs PSURs PADERs etc.)
Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials
Leads and implements risk management strategy for assigned products
Key Stakeholders:
Group Medical Director Executive Director TA head PST Lead Analytics / Data Scientists Project Management and Data Management Clinical Development Preclinical Safety Precision Medicin
Qualifications :
MD / DO with 2 years of residency with patient management experience
2 4 years of Pharmacovigilance experience in the pharmaceutical industry
Effectively analyze and guide analysis of clinical data and epidemiological information required
Effectively write technical documents with direction
Ability to effectively present recommendation / opinions in a group environment
Fluency both written and oral in English
Self-starting and can work independently
Work collaboratively and lead cross-functional teams
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Yes
Employment Type :
Full-time
Employment Type
Remote
Company Industry
Key Skills
- EMR Systems
- Post Residency Experience
- Occupational Health Experience
- Clinical Research
- Managed Care
- Primary Care Experience
- Medical Management
- Utilization Management
- Clinical Development
- Clinical Trials
- Leadership Experience
- Medicare
